(91 days)
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested. "
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
ExtraWear™, Gentlemen's Choice™, Extra Strength Latex Condom with Nonoxynol-9
The provided document is a 510(k) premarket notification letter and the "Indications for Use" statement for a medical device (a latex condom). It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML device evaluations. This document is from 1997, predating the widespread use of AI/ML in medical devices and the associated rigorous evaluation frameworks.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies from these documents. The questions in the prompt are structured around modern AI/ML device validation, which is not applicable to a 1997 condom approval document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Re: K970791
ExtraWear™, Gentlemen's Choice™, Extra Strength Latex Condom with Nonoxynol-9 Dated: February 28, 1997 Received: March 4, 1997 Regulatory class: II 21 CFR §884.5310/Product code: 85 LTZ
Dear Ms. Thomas:
3111 West Post Road
Ms. Lillie C. Thomas, M.S.
Las Vegas, Nevada 89118
Executive Director of Quality Assurance
Custom Services International, Inc.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (2) CFF Part 820) and that, through periodic the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 53 1 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notafication. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hikai Yi
Lillian Yih, Ph.D.
Lilian Yin, Ph.D. Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
CSI INC INSERVERSIERE, SUDE
F. 175
Page 1 of 1
510(k) Number: K970791
Condom (rubber) Contraceptive 85-LTZ Device Name:
Indications for Use:
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested. "
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
Date Submitted:
February 28, 1997
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K970791 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).